(63 days)
C. albicans PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Candida albicans from blood cultures.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to AdvanDx Inc. regarding their C. albicans PNA FISH device. This document primarily focuses on FDA clearance for market entry based on substantial equivalence to a predicate device. It defines the device, its intended use, and regulatory classification.
However, the document does not contain the acceptance criteria or the details of a study proving the device meets those criteria, as requested in the prompt. Specifically, the following information is not provided:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
This document merely confirms that the device has been found substantially equivalent to a legally marketed predicate device, enabling it to proceed to the market. Details about specific performance studies and their results are typically found in the 510(k) submission itself, not in the FDA's clearance letter.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AdvanDx Inc. c/o Ms. Amy Aulwes Vice President Health Policy Associates, Inc. 690 Canton Street, Suite 302 Westwood, MA 02090
OCT 2 5 2006
Re: K062461
Trade/Device Name: C albicans PNA FISH Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism Differentiation and Identification Device Regulatory Class: Class I Product Code: NZS, JXB Dated: October 17, 2006 Received: October 18, 20()6
Dear Ms. Aulwes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally attom
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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2A. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ KO62461
Device Name: C. albicans PNA FISH
Indications for Use:
C. albicans PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Candida albicans from blood cultures.
Over-The-Counter Use Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Freddie W. Pool
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safet 510(k
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.